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WO2000045724A1 - Vis a os - Google Patents

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Info

Publication number
WO2000045724A1
WO2000045724A1 PCT/CH1999/000049 CH9900049W WO0045724A1 WO 2000045724 A1 WO2000045724 A1 WO 2000045724A1 CH 9900049 W CH9900049 W CH 9900049W WO 0045724 A1 WO0045724 A1 WO 0045724A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone screw
screw according
silver coating
compatible material
threadless
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CH1999/000049
Other languages
German (de)
English (en)
Inventor
Michael Ahrens
Urs Schlegel
Silvia Beer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AO Technology AG
Synthes USA LLC
Original Assignee
Synthes AG Chur
Synthes USA LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synthes AG Chur, Synthes USA LLC filed Critical Synthes AG Chur
Priority to PCT/CH1999/000049 priority Critical patent/WO2000045724A1/fr
Priority to CA002360904A priority patent/CA2360904C/fr
Priority to AU20446/99A priority patent/AU757391B2/en
Priority to EP99900870A priority patent/EP1148830A1/fr
Priority to JP2000596849A priority patent/JP4230668B2/ja
Priority to ZA200000450A priority patent/ZA200000450B/xx
Publication of WO2000045724A1 publication Critical patent/WO2000045724A1/fr
Priority to US09/920,730 priority patent/US6663634B2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/866Material or manufacture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/082Inorganic materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/082Inorganic materials
    • A61L31/088Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00395Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00419Other metals
    • A61F2310/0052Coating made of silver or Ag-based alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104Silver, e.g. silver sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the invention relates to a bone screw according to the preamble of claim 1 and an external fixator with such a bone screw according to claim 16.
  • CH 657 519 BLAETTLER has disclosed a surgical implant completely coated with silver.
  • the silver layer is not applied directly to the carrier material but to an intermediate layer made of copper.
  • the disadvantage of this known device is that silver can have an inhibiting influence on the osteoblasts, depending on the concentration (typically 1.42 ⁇ g / ml), so that a bone screw coated in this way is nevertheless subject to the risks of loosening.
  • Pins have also been proposed, through which a silver-coated plastic tube is pushed down to the depth of the tissue down to the bone.
  • the disadvantage of this device is the lack of sterilizability, which precludes reuse. Since the diameter of the pins is doubled due to the tube being put over them, longer incisions are also required to insert them into the soft tissues, which increases the soft tissue trauma.
  • the invention seeks to remedy this.
  • the invention is based on the problem of creating a bone screw, in particular for use in an external fixator, which prevents the occurrence of infections.
  • the invention solves this problem with a bone screw, which has the features of claim 1.
  • the pins can be used as normal as conventional (uncoated) pins;
  • the pins are reusable after reprocessing and sterilization
  • the bone screw is only partially coated with silver, at least in the soft tissue area to be protected against infections.
  • the threaded part is uncoated, since silver in direct contact with the bone can have an inhibiting effect on the osteoblasts.
  • the rear part of the bone screw which is mechanically stressed by the clamping jaws of the fixator is preferably also uncoated.
  • the silver coating acts as the anode and the steel (or titanium) acts as the cathode.
  • the steel or titanium acts as the cathode.
  • a bactericidal effect mainly occurs on the anode.
  • Current stimulation in bone fractures showed a stimulating effect on the bone cells on the cathode.
  • a further increase in the antibacterial effect of the bone screw according to the invention can be achieved by applying an electric current in low strengths, for example 0.25 microamps.
  • a current of 5 to 20 microamps and approximately 0.8 volts is typically used.
  • the layer thickness of the silver coating is preferably greater than 10 ⁇ and can be applied to the body-compatible material either electrochemically or as a metallic film without an intermediate layer. Another possibility is to stick on the silver coating.
  • the coatings can thus be applied by different methods, e.g. electrochemical (anodizing) using IADB (ion assisted beam deposition using a foil (with conductive or insulating
  • Adhesives The coating-free areas can be covered with stencils.
  • the foils can be applied using a heat-resistant adhesive before sterilization, or sterile directly before insertion by the surgical nurse.
  • the body-compatible material can be steel, titanium, tantalum or niobium. It can also consist of polylactides, polyurethanes, hydroxyapatites, glasses, ceramics or carbon fibers.
  • the threaded front part should be at least 3 mm long to ensure sufficient anchoring in the bone.
  • the threadless back part of the bone screw should be between 2 and 3 cm long, because the drill chuck of the drill used to screw in the pins needs about 2 cm to clamp the pins and another centimeter should remain silver-free so that the silver coating just slightly projects above the skin level, because in addition to the area for the drill chuck, the jaws also cause mechanical abrasion.
  • the coated surface 0 Aq should preferably make up 10% of the total surface O tot of the bone screw.
  • a preferred development of the invention consists in that the bone screws according to the invention are only partially provided with a silver coating even in the non-threaded shaft part, e.g. with rings alternating in the axial direction.
  • the alternating surface rings made of biocompatible material (e.g. steel) and silver initially cause silver ions to flow out into the soft tissue area. Since the difference in charge decreases with time and the exchanged ions, a predetermined amount of silver ions can be released. Although this embodiment no longer permits the pins to be re-sterilized, it does take account of the requirement for controllable release of silver ions.
  • FIG. 1 shows a schematic illustration of the bone screw according to the invention
  • FIG. 2 shows a further embodiment of the bone screw according to the invention
  • FIG. 3 shows a further embodiment of the bone screw according to the invention.
  • Fig. 4 shows a further embodiment of the bone screw according to the invention.
  • the thread-bearing front part 1 and the threadless rear part 2 are uncoated and only the threadless shaft part 3 lying between them has a silver coating.
  • galvanic currents only occur at the interfaces between the rear part 2 and the threadless shaft part 3 on the one hand and between the threadless shaft part 3 and the front part 1 on the other hand.
  • the bone screw shown in FIG. 2 differs from the embodiment according to FIG. 1 only in the design of the threadless shaft part 3.
  • the threadless shaft part 3 is alternating in the axial direction in the form of rings 4 with a Silver coating.
  • the galvanic element lies in the area of the threadless shaft part 3; it causes an even flow of silver ions as a prophylaxis against infection.
  • the bone screw shown in FIG. 3 differs from the embodiment according to FIG. 1 only in the design of the threadless shaft part 3.
  • the threadless shaft part 3 is provided with longitudinal strips 5 with a silver coating in the axial direction.
  • the galvanic element lies in the area of the threadless shaft part 3; it causes an even flow of silver ions as a prophylaxis against infection.
  • the bone screw shown in FIG. 4 differs from the embodiment according to FIG. 1 only in the design of the threaded front part 1.
  • the front part 1 is either completely coated with silver or only coated with silver on the threads.
  • the version with a front part 1 completely coated with silver is particularly suitable for use on an already infected bone, where a high silver concentration is required.
  • the front part 1 acts as a galvanic element.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La vis à os présentée est faite en matériau biocompatible et comporte une partie avant filetée (1), une partie arrière non filetée (2) et une tige non filetée (3) située entre ces deux parties. Une partie OAg de la surface Otot de la vis à os est recouverte d'une couche d'argent, recouvrant au moins partiellement la tige non filetée (3). Le reste de la surface (Otot-OAg), comprenant au moins la partie avant filetée (1), n'est pas recouverte. La vis à os empêche l'apparition d'infections.
PCT/CH1999/000049 1999-02-04 1999-02-04 Vis a os Ceased WO2000045724A1 (fr)

Priority Applications (7)

Application Number Priority Date Filing Date Title
PCT/CH1999/000049 WO2000045724A1 (fr) 1999-02-04 1999-02-04 Vis a os
CA002360904A CA2360904C (fr) 1999-02-04 1999-02-04 Vis a os
AU20446/99A AU757391B2 (en) 1999-02-04 1999-02-04 Bone screw
EP99900870A EP1148830A1 (fr) 1999-02-04 1999-02-04 Vis a os
JP2000596849A JP4230668B2 (ja) 1999-02-04 1999-02-04 骨ねじ
ZA200000450A ZA200000450B (en) 1999-02-04 2000-04-17 Bone plate.
US09/920,730 US6663634B2 (en) 1999-02-04 2001-08-03 Bone screw

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CH1999/000049 WO2000045724A1 (fr) 1999-02-04 1999-02-04 Vis a os

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US09/920,730 Continuation US6663634B2 (en) 1999-02-04 2001-08-03 Bone screw

Publications (1)

Publication Number Publication Date
WO2000045724A1 true WO2000045724A1 (fr) 2000-08-10

Family

ID=4551653

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH1999/000049 Ceased WO2000045724A1 (fr) 1999-02-04 1999-02-04 Vis a os

Country Status (7)

Country Link
US (1) US6663634B2 (fr)
EP (1) EP1148830A1 (fr)
JP (1) JP4230668B2 (fr)
AU (1) AU757391B2 (fr)
CA (1) CA2360904C (fr)
WO (1) WO2000045724A1 (fr)
ZA (1) ZA200000450B (fr)

Cited By (7)

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US8135466B2 (en) 2005-06-30 2012-03-13 Argentumcidalelectrics, Inc. Prophylactic bactericidal implant
US8858775B2 (en) 2007-10-03 2014-10-14 Accentus Medical Limited Method of manufacturing metal with biocidal properties
US8945363B2 (en) 2002-04-16 2015-02-03 Accentus Medical Limited Method of making metal implants
US9011665B2 (en) 2004-03-13 2015-04-21 Accentus Medical Limited Metal implants
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US6663634B2 (en) 2003-12-16
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AU2044699A (en) 2000-08-25
CA2360904C (fr) 2007-05-22
US20020029043A1 (en) 2002-03-07
AU757391B2 (en) 2003-02-20
EP1148830A1 (fr) 2001-10-31
ZA200000450B (en) 2000-09-06

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